Overview
Shape the Future of Pharmaceutical Excellence - Your Quality Leadership Awaits!
For our client, a leading pharmaceutical company in Switzerland specializing in analytical chemistry and GMP-compliant drug development, we are seeking an experienced Quality Assurance Manager (m/f/d). This innovative organization is renowned for its cutting-edge analytical services and maintains a strong position in the global pharmaceutical market through advanced quality management systems and regulatory compliance expertise.
Responsibilities
* Lead comprehensive quality documentation processes including SOP reviews, protocol approvals, analytical reports, and Certificate of Analysis validation
* Drive quality investigations for deviations, Out of Specification (OOS) events, and implement robust corrective and preventive action (CAPA) systems
* Orchestrate customer audits and regulatory inspections while ensuring full compliance with international standards
* Serve as primary QA liaison for customer relationships and technical quality inquiries
* Manage Quality Management Software systems including administration, maintenance, and user training coordination
* Facilitate GMP training programs and ensure team competency in regulatory requirements
* Apply regulatory frameworks including ICH, FDA, USP, and Ph. Eur. guidelines to daily operations
* Support data integrity initiatives and computerized systems validation projects
Your Profile
* Master's degree in analytical chemistry, biochemistry, life sciences, or related scientific discipline
* Minimum 7 years of industrial experience in analytical-pharmaceutical environments with strong QA background
* Deep regulatory knowledge of GMP frameworks, ICH guidelines, FDA requirements, and European Pharmacopoeia standards
* Proven expertise in data integrity principles and computerized systems risk assessment methodologies
* Strong analytical and problem-solving capabilities to address complex business challenges effectively
* Excellent interpersonal and collaboration skills for cross-functional matrix environment success
* System administration experience or advanced IT knowledge considered a valuable asset
* Fluent English proficiency with willingness to develop German language skills
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